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Completed

NCT Number: NCT01551784

An Observational Study of Statin Treatment Induced HDL Changes

The aim with this study is to investigate the effect of statin induced changes in HDL-C on all cause mortality and CVD with adjustment for changes in other blood lipids and clinical parameters in Sweden, UK and the Netherlands.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Observational

About this study

An observational study of statin treatment induced HDL changes - effect on cardiovascular disease

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Started treatment with statins within the observation period (2004-2010)
  • The patient must have valid baseline and follow-up measurements for HDL-C and LDL-C.

Exclusion criteria

  • Malignancy Alcohol abuse/alcohol dependence

Treatment and study plan

Primary outcomes

  1. Time to first occurrence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke related to changes in HDL-C

    Time frame: 1st of January 2004 to 31st December 2010

Secondary outcomes

  1. The effect of statin induced changes in HDL-C (per mmol/L) on a composite endpoint including unstable angina pectoris, myocardial infarction, ischemic stroke and all cause mortality.

    Time frame: 1st of January 2004 to 31st December 2010

  2. Time to first occurence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke and ischemic heart disease mortality related to changes in HDL-C.

    Time frame: 1st of January 2004 to 31st December 2010

  3. The relationships between acquired HDL levels after statin treatment on the primary endpoint and the effect of HDL increase on the primary endpoint for different levels of baseline HDL

    Time frame: 1st of January 2004 to 31st December 2010

  4. Potential interactions between baseline HDL and HDL increase and other factors like age, gender, treatment and co-morbidity on the primary endpoint

    Time frame: 1st of January 2004 to 31st December 2010

  5. The health economic consequences of increasing HDL-C with statin treatment

    Time frame: 1st of January 2004 to 31st December 2010

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Observational Study of Statin Treatment Induced HDL Changes - Effect on Cardiovascular Disease

Acronym: SIRIUS

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 13, 2012
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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